Associate Director Regulatory Affairs

Recruiter
Umbilical Life
Location
All Saints
Posted
11 Feb 2018
Closes
21 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Core Responsibilities Accountable for maintaining a process and establishing standards to ensure that promotion for products in markets supported comply with company policies and SOPs. Support EU/ROW marketing and medical teams by participating in strategy discussions and extended team meetings. Provide regulatory strategy, guidance, and consultation on marketing strategies and promotion objectives and tactics as well as medical education tactics. Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure. Responsibilities Maintain a deep and current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to advertising and promotion. Determining work processes and resource needs, and must be knowledgeable in applying the IFPMA, ABPI, EFPIA codes of conduct and build a network to ensure adherence to local country regulations and codes of conduct for markets where our products are marketed. Experience Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred Expertise with ATMP/Gene Therapy, Medical Devices, or Vaccines Minimum of 10 years of increasingly responsible experience in the pharmaceutical industry. Experience in clinical trials, regulatory agency scientific advice meetings and business development is preferred CRO/Consulting and customer facing experience is preferred Expert knowledge of ICH and other global regulatory guidelines In-depth knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc

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